Objective: To investigate stability of Shenmai injections with different solubilizer and explore a solubilizer for replacing polysorbate 80. Method: Shenmai injections was prepared with 15-hydroxy polyethylene glycol stearate(0.2%) and polysorbate 80(0.5%) as solubilizer

respectively.With appearance

insoluble particles

visible particles

fingerprint similarity

pH and content of ginsenosides as indexes

stability of Shenmai injections was investigated

including influencing factor test(lighting

high temperature

low temperature

freezing and thawing)

long-term stability test in 25℃ and acceleration test in 40℃.UV was adopted to determine content of total saponins with detection wavelength at 544 nm;content of ginsenosides was determined by HPLC

mobile phase of acetonitrile(A)-water(B) for gradient elution(0-30 min

0%-10%A;30-40 min

10%-23%A;40-50 min

23%A;50-85 min

23%-60%A;85-95 min

60%-100%A) and detection wavelength at 203 nm. Result: Appearance

insoluble particles and visible particles of Shenmai injections with different solubilizer were in line with regulations

fingerprint similarity were 0.98

content of ginsenosides had no significant difference. Conclusion: Compared with polysorbate 80

15-hydroxy polyethylene glycol stearate had the same solubilization effect

prepared Shenmei injections had good stability.